Epigenomics AG - Corporate Presentation - July 2015

Epigenomics AG 

July 2015 

www.epigenomics.com

Safe Harbor 

• Forward Looking Statements 

This communication contains certain forward-looking statements, including, without limitation, statements containing 

the words “expects”, “future”, “potential” and words of similar import. Such forward-looking statements involve known 

and unknown risks, uncertainties and other factors, which may cause our actual results of operations, financial condition, 

performance, or achievements, or industry results, to be materially different from any future results, performance or 

achievements expressed or implied by such forward-looking statements. Such factors include, among others, the following: 

uncertainties related to results of our clinical trials, the uncertainty of regulatory approval and commercial uncertainty, 

reimbursement and drug price uncertainty, the absence of sales and marketing experience and limited manufacturing 

capabilities, attraction and retention of technologically skilled employees, dependence on licenses, patents and proprietary 

technology, dependence upon collaborators, future capital needs and the uncertainty of additional funding, risks of 

product liability and limitations of insurance, limitations of supplies, competition from other biopharmaceutical, chemical 

and pharmaceutical companies, environmental, health and safety matters, availability of licensing arrangements, currency 

fluctuations, adverse changes in governmental rules and fiscal policies, civil unrest, acts of God, acts of war, and other 

factors referenced in this communication. Given these uncertainties, prospective investors and partners are cautioned not 

to place undue reliance on such forward-looking statements. We disclaim any obligation to update any such forwardlooking 

statements to reflect future events or developments. 

• Legal Product Disclaimer 

Products by Epigenomics that are referred to in this presentation, especially Epi proColon®, are not available and are not 

approved for sale in the United States. The analytical and performance characteristics of any product to be eventually sold 

in the U.S. based on our technology have not been established. 

2 | July 2015

‣ Overview 

‣ Epi proColon® 

• Unmet need & commercial opportunity for Epi proColon® 

• Commercial strategy 

‣ Epi proLung® and future product opportunities 

‣ Financial information and outlook 

‣ Appendix 


DNA Methylation Diagnostic Products for Oncology 

Epi proColon® 

blood-based 

colorectal cancer (CRC) screening 1,2 

Epi proLung® 

tissue assay for 

lung cancer diagnosis 1 

Addressing low compliance to 

currently available CRC screening 

Aid in difficult to diagnose lung cancer 

development of blood based assay 

1 

CE marked and commercially available in Europe 2 under FDA review and not commercially available in the U.S. 


‣ Overview 






‣ Appendix 


Fighting a Treatable Disease: Colorectal Cancer 

Public Health Impact 

90% 5-year survival rate in stages I and II 

>136,000 new cases and 50,000 deaths 1 

Health Economic Impact 

US$ 14 Bn CRC treatment cost p.a. 2 

Over a third in late stage disease 

Colonoscopy every 10y 

or annual FIT 3 

Screening 

is key! 

25-30 million people 

not screened for CRC 1 

1 

ACS Cancer Facts & Figures 2014, 2 Centers for Disease Control. "Vital signs: Colorectal cancer screening, incidence, and mortality ---United States, 2002-2010 " MMWR Morb. Mortal. 

Weekly Report. 2011, 60(26):884-889. 3 recommendation of the U.S. Preventive Services Task Force (USPSTF) for people aged between 50-75 years, 


•Goal: Increase in Screening Participation to 80%+ 

• Campaign by ACS to get 80% screened by 2018 

• Reaching that goal would save over 200,000 lives 1 

• Simple blood test can significantly contribute to this goal 

1 

http://onlinelibrary.wiley.com/doi/10.1002/cncr.29336/abstract 


Blood Testing: More Options for Physicians and Patients 

Imaging methods 

colonoscopy 

flexible sigmoidoscopy 

virtual colonography 

ingestible devices 

etc. 

Stool sampling 

fecal occult blood (FOBT) 

immunochemical (FIT) 

etc. 

Blood based 

Epigenomics: 

methylated Septin9 


Demonstrated: Blood Testing Increases Compliance 

• 63% refused colonoscopy screening: 

83% opted for Septin9 blood test 1 

• Surveys in the U.S. confirm these results 2 

• Patient choice of methods has shown 

to increase screening compliance 3 

• Recently completed ADMIT study in the US 

showed 99.5% compliance to blood test in 

previously non-adherent patients 

1 

Study performed at Charité University Hospital, Berlin (Germany): Adler et al, BMC Gastroenterology 2014, 14:183 doi:10.1186/1471-230X-14-183 2 Taber et al. (2012, ASPO) 

Preferences for a methylated DNA blood test for colorectal cancer among a multiethnic sample of screened and unscreened adults, 

3 

Inadomi J et al. Adherence to colorectal cancer screening, a randomized clinical trial of competing strategies, 2012 


Epi proColon®: Simple and Efficient for Patients and Customers 

• Easy for the patient part of routine visits; no dietary restrictions 

• Easy for the doctor Septin9 (+): colonoscopy Septin9 (-): return next year 

• Easy for the lab runs on existing hardware (validated for ABI, Roche) 


Epi proColon®: Powerful Screening Tool with Flexible Set Up 


(under US FDA review) 

Epi proColon® 2.0 CE 

(CE marked, CFDA) 

+ + + 

test result 

positive (+) 

test result 

positive (+) 

10 ml blood sample 

- + + 

follow-up with 

colonoscopy 

follow-up with 

colonoscopy 


test result 

(3x15ul) 

- - + 

min. 45 μl DNA 

- - - 

negative (-) 

negative (-) 


Epi proColon®: Validated in Clinical Trials 

• US data generated in 

prospective trials 

for FDA submission 1 

+ + + 

US product 1,2 

Sensitivity 

68-73% 

China/EU 

product 3,4 

Sensitivity 

75-81% 

• Non-inferiority to FIT 

demonstrated in headto-head 

study 2 

(FIT sensitivity: 68%) 

- + + 

Specificity: 

80-82% 

Specificity: 

97-99% 

• Case control studies 

in Europe and China 

using the “2 out of 3” 

algorithm 3,4 

- - + 

- - - 

1 

Potter et al. , Clinical Chemistry June 2014 clinchem.2013.221044 “Validation of a Real-Time 

PCR-Based Qualitative Assay for the Detection of Methylated Sept9 DNA in Human Plasma“, 2 Approx. 100 CRC cases from screening eligible patients and ~200 prospectively collected 

normal controls ; Non-inferiority (sensitivity) to OC-FIT-Chek proven in study 3 Case control study performed in Europe, 100 CRC cases, 148 normal controls, 4 Jin et al., accepted for publication 


Regulatory Status of Epi proColon® 

U.S.A.: 

• PMA under review by US FDA since early 2013 

• Advisory Panel Meeting and Response letter 

(June 2014): FDA request for additional data supporting 

assumption that blood test will increase compliance to CRC screening 

• ADMIT trial successfully completed in May 2015, data submitted to FDA 

• Awaiting FDA decision on approval 

Europe: 

• Commercially available since 2012 – growing sales but at low levels since no 

active commercial effort underway for the time being – CE marking based approval 

in other countries, e.g. Argentina 

China: 

• Approved in China in December 2014 – commercialization by BioChain started 


‣ Overview 






‣ Appendix 


Joint Commercialization Agreement with Polymedco 

• Market leader in the CRC screening field 

• Ideally positioned (CRC focus) to address 

>10M FIT tests p.a. sold 

>1,500 existing laboratory customers 

Epigenomics: 

MANUFACTURING 

IP 

REGULATORY 

CLINICAL 

MEDICAL NETWORKS 

PRODUCT 

Joint Efforts: 

KEY ACCOUNTS 

REIMBURSEMENT 

STRATEGIC 

MARKETING 

CHANNEL 

Polymedco: 

MARKETING 

SALES 

DISTRIBUTION 

CUSTOMER SUPPORT 

BILLING 

COLLECTION 


Value Chain of Septin9 based CRC Screening 

pays COGS 1 

profit share 

- Guidelines - 

sells to 

laboratories 

US$ 75-90 2 

orders 

test 

Reference Laboratories 

provides 

result 

Healthcare Professionals 

invoices 

payers 

US$ 141 2 

- Payors - 

1 

Cost of goods sold (COGS ) 2 Company estimates 


Blood Testing to drive Market Expansion 

• Health economic benefit demonstrated 1 

Septin9 based screening proven to be cost-effective 

Incremental U.S. market opportunity 

estimated in excess of US$ 1 Bn annually 2 

1 

U. Ladabaum et al. 2 Company and Analyst estimates 


Key Elements for Successful U.S. Market Penetration 

Reimbursement 

Medical Guidelines 

first 6 

months 

generate health economic data 

expert groups / 

medical societies 

7-18 

months 

ensure reimbursement 

selected KOL studies 

>18 

months 

governmental endorsement 

guideline inclusion 


Strategic Collaboration with BioChain in China 

• Stage 1: Epi proColon® approved in China by CFDA 1 

• BioChain has started its commercialization in 2015 

• Pricing and reimbursement discussions underway 

• Stage 2: License to develop and commercialize Septin9 IVD tests 

• Development underway, submitted to CFDA 

• Epigenomics has the rights for the rest of the world 

Enormous market opportunity – 

CRC incidence increasing – 

290M people screening eligible in China 

1 

China Food and Drug Administration (CFDA) 


Chinese Guideline for Colon Cancer Diagnosis 

• Publication of the ”Chinese Guideline on Screening, 

Endoscopic Diagnosis and Treatment of Early Colorectal 

Cancer” on June 30, 2015. 

• Septin9 test has been clearly stated as the method 

for screening early colon cancer 

• Guideline authored 50+ leading experts of the 

Chinese Society of Endoscopy and The Society of 

Oncological Endoscopy of Chinese Anti-Cancer 

Association 


‣ Overview 






‣ Appendix 


Epi proLung®: Diagnosis of Lung Cancer 

• Diagnosis of lung cancer in 

bronchial lavage 

• Biomarker: methylated SHOX2 1 

• CE-marked IVD test in Europe 

1 

Kneip et al., „SHOX2 DNA Methylation Is a Biomarker for the Diagnosis of Lung Cancer in Plasma”. Journal of Thoracic Oncology, Vol 6, Number 8, August 2011 


Epi proLung®: Diagnosis of Lung Cancer 

Epi proLung® plus cytology 1 combined resulted in clinical sensitivity of 98% 

1 

Klauschen et al., „Performance of Epi proLung in combination with cytology in bronchial lavage samples from clinical routine“. In preparation 


Epi proLung®: Next Steps 

• Development of blood-based version underway 

• Demonstrated applications in treatment response 

monitoring 1 

• More rapid and sensitive determination than CT scan 

• Possible initial application in follow-up of positive results 

in low dose spiral CT 

• Attractive future opportunity in screening of high risk patients 

• EUR 2.8M grant from European Union received for development 

1 

Fleischhacker et al. PLoS ONE 10(2): e0118195. doi:10.1371/journal.pone.0118195 


R&D Capabilities and Future Product Opportunities 

Biomarker discovery, 

confirmation and selection 

IVD test development, 

validation and regulatory 

>20 proprietary prognostic, predictive, response, diagnostic, 

and screening biomarkers in cancer indications 

• Potential to evaluate and clinically validate in collaboration with BioChain 

• Broad IP protection with 70 active patent families: protection along the value chain 

• Epigenetic biomarker discovery and IVD development capabilities 


‣ Overview 






‣ Appendix 


Key Financial Information 

(in € thousand) 

Q1 2015 Q1 2014 

Revenue 367 407 

EBIT (Operating Result) -3,164 -2,000 

Net loss -3,164 -2,240 

Cash consumption -2,288 -1,475 

(in € thousand) 

Mar 31, 2015 Dec 31, 2014 

Liquid Assets* 6,421 7,495 

* incl. marketable securities 

• Liquid assets to fund operations until after expected US launch of Epi proColon® 

• Capital Increase of EUR 5.0M successfully completed 

• Up to EUR 6.8M additional cash inflow in 2015 possible from 

conversion of outstanding bonds (EUR 1.6M so far since end of Q1 2015) 


Shareholder Structure 

Type of shares 

Security code number 

ISIN 

Stock Exchange 

ADR program 

Ratio 

Ticker Symbol 

Total Shares 

Outstanding 

registered shares 

A11QW5 

DE000A11QW50 

Frankfurt Stock Exchange, 

Prime Standard: ECX 

Sponsored Level 1 ADR 

1 ADR = 5 common shares 

EPGNY 

17,476,609 1 

(19.9m fully diluted) 

BioChain 9.1% 2 

Abingworth 4.9% 2 

Deerfield 3.1% 2 

Freefloat 82.9% 

Analyst coverage 

Edison 

Equinet 

First Berlin 

Kempen & Co 

Maxim 

All issued „buy“ recommendations..... 

1 

As of June 30, 2015 2 According the published voting right notifications 


Outlook 2015/ 2016 – Expected major milestones 

Start U.S. 

Commercialization 

Development 

bloodbased 

Epi proLung® 

test 

CFDA 

approval 

for 

BioChain‘s 

Septin9 

test 

Launch 

BioChain‘s 

Septin9 

test in 

China 

2015 2016 

FDA 

Approval 

for Epi 

proColon® 

in the U.S. 

BioChain 

Septin9 

product 

under 

CFDA 

Review 

Start clinical 

validation study 

with bloodbased 

Epi 

proLung® test 

CE-marking 

new Epi pro 

Lung® test 


Why to Invest in Epigenomics 


the world’s first IVD blood test 

intended for CRC screening 

convenient 

Not for sale or diagnostic use in the United States of America 

accurate 

effective 


Thank you for your attention! 

Contact Investor Relations 

Europe 

Antje Zeise 

Manager Investor Relations 

Epigenomics AG 

T. +49 30 24345 386 

ir@epigenomics.com 

U.S.A. 

Brian Korb 

Managing Director 

The Trout Group LLC 

T. +1 646 378 2923 

BKorb@troutgroup.com 

TICKER 

Bloomberg: ECX:GR 

Reuters: EXXG.DE 

Thomson ONE: ECX-XE 

ADR OTC: EPGNY 

INTERNET 

www.epigenomics.com 

www.epiprocolon.com 

www.epiprolung.com 

www.epigenomics.com

‣ Overview 






‣ Appendix 


Methylated Septin9 – Blood Based Test for CRC Detection 

• Simple blood-based tests widely seen as 

best way to close the “screening gap” 

• Epi proColon® is based on a single 

epigenetic biomarker: methylated Septin9 

• Septin9 in CRC tissue fully methylated in 

>95% of all cancers 

• High analytical sensitivity (6pg/ml), 

specific for colorectal cancer 

• Equal capability to detect left and right 

sided cancerous lesions 


Possible Performance Improvement (post-hoc analysis 1,2 ) 

+ + + 

- + + 

positive (+) 

(3% of all cases) 

re-test with FIT: 

65% sensitivity 

96% specificity 

overall combined performance 1 

- - + 

- - - 

“1 out of 3“ 

or “weak” positives 


negative (-) 


re-test 

re-test with Epi proColon: 

70% sensitivity 

90% specificity 

overall combined performance 2 

1 

Based on post-hoc analysis of FIT/Sept9 comparison study 2 Based on post-hoc analysis of FIT/Sept9 comparison study and retesting of „weak positive“ results with Epi proColon® 


Comparison Study Top Line Data: 

Cancer Detection by Stage from head-to-head FIT/Septin9 trial 

Epi proColon® pT0/Tis pT1 pT2 pT3 pT4 pTx unknown TOTAL 

Stage 0 / I 2/3 6/11 10/13 - - - 0/1 18/28 64.3% (45.8-79.3%) 

Stage II - - - 14/18 2/2 - - 16/20 80.0% (58.4-91.9%) 

Stage III - 0/1 0/2 14/19 1/1 - - 15/23 65.2% (44.9-81.2%) 

Stage IV - 2/2 - 0/1 6/6 1/1 3/3 12/13 92.3% (66.7-99.6%) 

Unknown* - - - - - 3/3 10/14 13/17 76.4% (52.7-90.4%) 

TOTAL 

*…Staging information incomplete or unavailable 

2/3 8/14 10/15 28/38 9/9 4/4 13/18 74/101 

FIT pT0/Tis pT1 pT2 pT3 pT4 pTx unknown TOTAL 

73.3% (63.9- 

80.9%) 

Stage 0 / I 0/3 5/11 11/13 - - - 1/1 17/28 60.7% (42.4-76.4%) 

Stage II - - - 14/18 2/2 - - 16/20 80.0% (58.4-91.9%) 

Stage III - 1/1 1/2 16/19 1/1 - - 19/23 82.6% (62.9-93.0%) 

Stage IV - 1/1 - 0/1 4/6 1/1 1/3 7/12 58.3% (32.0-80.7%) 

Unknown* - - - - - 1/3 6/11 7/14 50.0% (26.8-73.2%) 

TOTAL 

*…Staging information incomplete or unavailable 

0/3 7/13 12/15 30/38 7/9 2/4 8/15 66/97 

68.0% (58.2- 

76.5%)

Epigenomics AG - Corporate Presentation - July 2015

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